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Regulatory Services
Regulatory Consulting
Preparation of CTD Dossiers for Products (Manufacturing/Importation/Exportation)
Preparation of Type Variation (Type IA, Type IB, Type II Variation) Dossiers
Preparation and Revision of SmPCs/PILs
Implementation and Reporting Readability Tests
Quality Control of Braille on Packaging Materials
Preparation of GMP Audit Application Dossiers
Renewal and Transfer of Marketing Authorisation
Applications for Medical Devices
Preparation of Food Supplement Application Dossiers
Notifications for Cosmetics
Translation Services
Written Translation Services
Interpretation Services
Notary Translation Services
References
Contact
Regulatory Affairs Services
Applications for Medical Devices
Applications for Medical Devices
Preparation of necessary documentation for company registration at the local health authorities if the company is not registered
Classification of documentation according to Medical Device Classification and notifying the company
Registration of products or documents in the Turkish Medicines and Medical Devices National Database (TITUBB)
Follow-up of the process